Posts tagged ‘mobile health’

The Food and Drug Administration (FDA), which regulates everything from heart monitors to horse vaccines, will soon have its hands full with consumer health apps and devices.

The vast majority of the health apps you’ll find in Apple’s or Google’s app stores are harmless, like step counters and heart beat monitors. They’re non-clinical, non-actionable, and informational or motivational in nature.

But the next wave of biometric devices and apps might go further, measuring things like real-time blood pressure, blood glucose, and oxygen levels. More clinical apps

The FDA is charged with keeping watch on the safety and efficacy of consumer health products. Lately, that includes more clinical apps as well as devices you might buy at the drugstore, like a home glucose testing kit.

“It’s these apps that the FDA says it will regulate,” David Bates of Brigham and Women’s Hospital and Physicians Organization told VentureBeat in June. These apps will have to go through the full 510(k) process,” he said.

Dr. Bates chaired a group to advise the FDA on how to review health apps for approval, and on how the FDA should advise developers.

“It was intended to help them think through the risk factors involved with these products and then give guidance on how to stay within the guidelines,” he said.

“The device makers were asking from some guidance from The FDA on what types of things would be accepted and what wouldn’t,” Bates said.

Bates believes the FDA wants to use a light regulatory touch when looking at new medical devices. “The FDA definitely wants innovation to continue in clinical devices,” he said. “In general the FDA knows that the vast majority of apps are just informational.”

The FDA’s final guidance focuses on a small subset of mobile apps that present a greater risk to patients if they do not work as intended.

Health apps go mainstream

The big software companies (Apple, Google, and Samsung) have brought attention to, and lent credibility to, apps and devices that do more than count steps. These companies are building large cloud platforms designed to collect health data from all sorts of health apps and devices.

After decades as a technological laggard, medicine has entered its data age. Mobile technologies, sensors, genome sequencing, and advances in analytic software now make it possible to capture vast amounts of information about our individual makeup and the environment around us. The sum of this information could transform medicine, turning a field aimed at treating the average patient into one that’s customized to each person while shifting more control and responsibility from doctors to patients.

The question is: can big data make health care better?

“There is a lot of data being gathered. That’s not enough,” says Ed Martin, interim director of the Information Services Unit at the University of California San Francisco School of Medicine. “It’s really about coming up with applications that make data actionable.”

The business opportunity in making sense of that data—potentially $300 billion to $450 billion a year, according to consultants McKinsey & Company—is driving well-established companies like Apple, Qualcomm, and IBM to invest in technologies from data-capturing smartphone apps to billion-dollar analytical systems. It’s feeding the rising enthusiasm for startups as well.

Venture capital firms like Greylock Partners and Kleiner Perkins Caufield & Byers, as well as the corporate venture funds of Google, Samsung, Merck, and others, have invested more than $3 billion in health-care information technology since the beginning of 2013—a rapid acceleration from previous years, according to data from Mercom Capital Group. more at http://www.technologyreview.com/news/529011/can-technology-fix-medicine/ ;

Psychiatric health conditions and behavioral issues received greater prominence at the 2013 mHealth Summit, with presentations and panelsgiven by prominent national researchers. This focus comes at the right time, when today’s mental health system is extremely dysfunctional.

For mobile health to become more mainstream, companies will have to provide tools that add value, save time and get the blessing of the U.S. Food and Drug Administration. Today, Kinsa said the FDA gave 510(k) clearance to its Smart Thermometer, according to an emailed statement. It’s used with a smartphone to generate readings.

The FDA device approval fits into a broader movement in the future of mobile technology in healthcare to increase the capacity of smartphones to help people track their health and make informed decisions based on the results.

The thermometer connects to the headphone jack of smartphones and other mobile devices. The display shows reading progress and alerts parents if the thermometer slips out of place. It also shows images to distract children as it measures their temperature.

Users can create individual profiles and track their fever, symptom and illness history.

In a statement, the company said it is conducting a private beta test of the device this month and expects to start delivering the Smart Thermometer in March or April.

One of its backers is IA Ventures, but it has also raised money with crowdfunding campaigns on Indiegogo and AngelList. It also won in the consumer category of the DC to VC competition.

Inder Singh, founder and CEO of Kinsa, is a former executive vice president for Clinton Health Access Initiative, a public health organization that claimed success reducing drug prices for AIDS, malaria, and TB medicines in more than 70 developing countries

John Branston discusses how mobile research brings us closer to the patient in our mobile health themed month. For many years, marketing teams focused on how to influence physician share of voice and did little more than pay lip service to the…

John Branston discusses how mobile research brings us closer to the patient in our mobile health themed month.

For many years, marketing teams focused on how to influence physician share of voice and did little more than pay lip service to the notion that patients were at the centre of the provision of healthcare. Now there is recognition that the success of many medications depends not only on the hard-won clinical advantage, but also on how patients negotiate key moments in their experience of their disease. Increasingly, marketing effectiveness is being improved by an enhanced understanding of the picture that emerges when the dots of the longitudinal patient experience are joined. This in turn leads to an increased need to understand those touch points in greater detail and something of a challenge to market researchers to deliver better and more targeted insights.

We have seen marketing effectiveness greatly improved by a better understanding of the patient. Going forward, the pressure is on market research to deliver better and more targeted insights. As a market researcher, the recent advent of mobile research techniques has been very timely in enabling access to the patient experience and getting marketers closer to the action.

New research techniques: mobile

One drawback of traditional patient research and ethnography has always been that it has been costly to conduct, whether relying on physician recruitment for larger numbers of patients, or employing an ethnographer to get up close with a very small number of individual patients.

Now we have the tools to conduct research using mobile devices such as smartphones and tablets (e.g. iPad) that are equipped with cameras, sound recording devices, GPS and other technology that, with a little inventive thought, can be harnessed to deliver valuable insight. Our target respondents not only own these devices in huge numbers (check out smartphone / tablet penetration in any given market), but take them with them pretty much everywhere they go. This means that we are able to uncover in-the-moment effects of disease in private, social and work situations, as well as focusing on the patient side of interface with healthcare provision.

Mobile health is an area that continues to grow as technology evolves day by day, and there are many opportunities for the pharmaceutical industry to get involved. Anna Field explores these opportunities in our mobile health themed month.

You may not think it, but the mobile phone has been around since 1946 when the first mobile call was made from a car in St Louis, Missouri in the United States. Since then, mobile phone technology has rapidly evolved. The answer to the question above ten years ago would most likely be “I made a call” but today’s responses could range from tweeting to playing Candy Crush. In today’s world, mobile phones are not only becoming increasingly common but are more and more vital to everyday life.

Along with the evolution of the mobile phone, computers have been progressing perhaps even faster. From internet cafes to tablets, we are in a new era of the personal computer. Today’s smart phones allow us to truly take our computers with us and every day are more an extension of ourselves. Because we spend so much time using our phones, there is a major opportunity upon which pharmaceutical companies and market research agencies can capitalize.

There’s an app for that!

In the iPhone app store alone, applications have burst to over 900,000 since 2008, almost 6,000 of which regard Health and Fitness. There really is an app for just about anything, and with the evolution of technology moving so rapidly, sometimes it’s hard to keep up. When it comes to mobile health, both physicians and patients can benefit.

“Because we spend so much time using our phones, there is a major opportunity upon which pharmaceutical companies and market research agencies can capitalize.”

Apps for physicians tend to focus on keeping up-to-date in their field, and these range from broadcasting continuing medical education (CME) podcasts to providing diagnostic advice.

The trend could be slowed, however, as app developers await regulatory guidance from the FDA.

Physicians should prepare for a dramatic increase in the number of patients using mobile devices to monitor and track their health. They also should be ready for mobile devices to become an integrated part of patient treatment plans.

This advice comes from a market report predicting that mobile health will become an increasingly important part of overall health care delivery. A report from research2guidance, a market research firm in Berlin, foresees that the mobile health market will grow by 61% to reach $26 billion by 2017. The majority of that growth will not come from app downloads, but rather hardware, including wearable sensors that will work in conjunction with downloaded apps. Also poised for growth are telemedicine services made possible through mobile devices. The report was published in July by the firm Research and Markets.

The report says mobile health is growing in three phases: pilot, commercialization and integrated. The industry is moving beyond the pilot phase and into the commercialization phase, which is described as a time when the industry will launch a variety of new applications and business models to support the growth.

Report author Ralf-Gordon Jahns, managing director of research2guidance, said physicians are starting to realize that there are great mobile solutions available to help them treat patients. The benefits of mobile technology for patient monitoring and behavior modifications have been cited in several use case studies, he said. Now physicians are looking for the best solutions to help patients. The report also said physicians will be delivering services such as remote consults through mobile devices.

America leads the way

Jahns said the U.S. is more advanced in the mobile health market than other countries because of its higher level of trust in mobile technology, as evidenced by the increasing interest in wearable sensors. A separate report in March from the San Diego research firm ON World also pointed to growth in the wearable sensor market. It said 515 million wearable sensors will be shipped globally by 2017, up from 107 million in 2012.

The integrated phase will involve the integration of mobile apps into traditional treatment plans. Insurers are expected to replace consumers as the primary purchasers of mobile health solutions. But, Jahns wrote, the biggest barrier to reaching the integrated phase is the lack of regulations. In the U.S., many are awaiting regulations from the Food and Drug Administration.

The FDA has indicated plans to regulate the mobile app market for certain apps, but hasn’t issued guidance on which apps will need oversight. The mHealth Regulatory Coalition said the lack of clarification from the FDA has left many developers in limbo. The coalition consists of organizations involved in or supporting mobile health as well as medical device and app developers who will be affected by FDA regulation.

“Right now, many companies are sitting on the sidelines and not developing higher-risk apps because the rules are unclear,” the coalition said in a policy statement published June 18. “They do not want to invest in developing a quality system, taking the time to develop evidence and submitting that evidence to the FDA as needed if their competition is going to be able to undercut them by not investing in FDA compliance.” The coalition is calling on the FDA to publish its guidance on mobile apps as soon as possible.